Kornimate/medical-research-clean huggingface dataset:
study of antitumor immune response after ccrt and io treatment in non-resectable iii stage nsclc patients

Conditions: Non-small Cell Lung Cancer Stage III; PDL1 Gene Mutation

Summary: observational, multicenter, one-arm, non-comparative study. data will be recorded in a retrospectively manner. the study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits. the primary objective is describe the antitumor immune response generated in the context of io (immunotherapy) treatment after ccrt in patients with unresectable nsclc treated in real world.

the study is based on the collection of blood samples and tumor sample analysis, in real world nsclc stage iiia/b and iiic; pd-l1\>1%; non-resectable patients on treatment with io after ccrt without progression. the patients participating in this study will not receive treatment in relation to the study, no drugs will be provided. patients will be treated as per standard clinical practice. all data collected for this study will be collected retrospectively from patient clinical chart. only secondary data collected will be analyzed together will samples analysis information.the duration of the study is expected to be 3 years.

Eligibility criteria:
inclusion criteria: * patients with histologically- or cytologically- documented nsclc who present unresectable stage iiia-iiib-iiic disease, according to 8th version of the international association for the study of lung cancer staging manual in thoracic oncology). * ecog 0-1. * pdl1\>1%. * age ≥ 18 years at time of study * patients without progression after ccrt, that are going to receive io treatment (durvalumab) for 12 months as subsequent treatment as per standard clinical practice * patient capable of proper therapeutic compliance and accessible for correct follow-up. * patients must have signed, dated and irb/ec-approved written informed consent form in accordance with regulatory and institutional guidelines. exclusion criteria: * patients who refuse to sign and date an irb/iec-approved written informed consent form. * no possibility of venipuncture * any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.

Keywords: lung cancer chemo radiotherapy ctdna inmunotherapy
low-level laser therapy vs. saline for wound healing after primary molar extraction.

Conditions: Wound-healing

Summary: to evaluate the effect of low level laser therapy versus the saline on wound healing after extraction of primary molars


Eligibility criteria:
inclusion criteria: * ● children aged from 4 to 6 years. * children of both genders. * medically fit asa i. * children with badly decayed primary molars beyond repair and indicated for extraction. * parents acceptance to participate in the study. * cooperative children. * antibiotics and painkillers have been stopped at least 12 hours prior to the procedure.(özer et al., 2024) * teeth with at least two-thirds of the root. exclusion criteria: * ● uncooperative children. * lack of informed consent by the child patient's parent to be approved ethically. * unable to attend follow-up visits to avoid attrition bias by decreasing the number of drop off cases. * medical history includes conditions such as prolonged bleeding, platelet disorders, hypersensitivity, allergic reactions to pain relievers, contraindications to laser therapy, and acute pain. * teeth with root lengths less than two-third of the normal root length or those who experienced extensive iatrogenic trauma during tooth extraction.

Keywords: laser therapy low-level wound healing molar extraction oral
tocilizumab treatment in graves´ ophthalmopathy (graves´ orbitopathy or thyroid eye disease)

Conditions: Thyroid Associated Ophthalmopathies; Graves´ Ophthalmopathy; Thyroid Eye Disease

Summary: the purpose is to investigate tocilizumab administration in patients with moderately to severely or sight-threatening go (graves' ophthalmopathy) without response to treatment with corticoid intravenous pulses. currently, these patients only have surgery as therapeutic alternative. the principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment in order to provide a better alternative to surgery for this patients.

thyroid orbitopathy or graves´orbitopathy (go) is manifested for inflammation of the orbital and periorbital soft tissues. ten percent of patients with go will have long-term serious eye problems. the cause of the go is complex. autoreactive t cells recognize an autoantigen, the tsh receptor present in the orbit and thyroid follicular cell, secrete cytokines (il-6), which stimulate the fibroblasts to synthesize glycosaminoglycan, which draws liquid produce periorbital edema and muscle, causing exophthalmos. this approach suggests that inhibition of il-6 can be an effective treatment for this problem on the basis that tocilizumab specifically binds to the receptors of the il-6, both soluble and membrane-bound. tocilizumab has been shown to inhibit signaling mediated for il-6rm il-6rs.

Eligibility criteria:
principal inclusion criteria: patients diagnosed go with cas ≥ 4 and an index of severity, according eugogo guidelines, 1. moderately to severely or 2. sight-threatening go, after receiving corticosteroid pulse treatment due to: * poor response to intravenous corticosteroid pulses or * recurrence of the go, after treatment with intravenous corticosteroids exclusion criteria: * orbital decompression surgery needed immediately * active smoker * patients who could need treatment with radioactive iodine or thyroidectomy during the study * pregnant patient or patient who is planning to become pregnant during the study * history of chronic recurrent or active infection * history of intestinal ulceration or diverticulitis * patients with a history of chronic liver disease or liver disorders: alanine aminotransferase (alt) and aspartate aminotransferase (ast) above 5 times upper limit of normal (uln) * history of hiv, hepatitis c or hepatitis b positive * neutrophil count \< 0.5 × 109/l or a platelet count \< 50×103/μl * simultaneous use or contraindications to the use of immunosuppressive agents * a treatment with another investigational drug within four weeks of selection or five half-lives of study drug * cardiovascular or cerebrovascular disease clinically significant * uncontrolled diabetes mellitus * use of corticosteroids during four weeks before to inclusion period * history of reactions or anaphylactic allergic severe human monoclonal antibodies, humanized or murine * uncontrolled pathologies, whose exacerbations are treated with corticosteroids

Keywords: graves´ orbitopathy graves´ ophthalmopathy thyroid eye disease thyroid-associated ophthalmopathy tocilizumab eugogo cas
comparison of nn1250 versus insulin glargine in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia and japan. the aim of this trial is to compare insulin degludec (nn1250) with insulin glargine both combined with oral antidiabetic drugs (oads) in subjects with type 2 diabetes never treated with insulin.


Eligibility criteria:
inclusion criteria: * for japan only: minimum age is 20 years * type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a dpp-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. the dose(s) should as minimum be as stated: -insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -metformin: alone or in combination (including fixed combination): maximum tolerated dose - alfa-glucosidase-inhibitors: minimum half of the daily maximal dose or maximum tolerated dose -dpp-4 (dipeptyl peptidase 4) inhibitor: according to local labelling * hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis * body mass index (bmi) no higher than 35.0 kg/m\^2 exclusion criteria: * use within the last 3 months prior to visit 1 of: tzds (thiazolidinediones), exenatide or liraglutide * cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg) * pregnancy, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.) * cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
influence of "espresso" on adsorption of myo-inositol

Conditions: Neural Tube Defects

Summary: neural tube defects (ntds) are multifactorial (genetic/environmental) diseases that arise from failure of embryonic neural tube closure. several studies have demonstrated that periconceptional administration of folic acid can prevent approximately 70% of all ntds cases. the finding of several ntds cases in a single family, despite prophylactic therapy with folic acid, suggested that a proportion of human ntds are folate-resistant. so far, no preventive therapy for folate-resistant ntds is available. studies performed on folate-resistant ntds animal models have shown that inositol is effective in preventing ntds occurrence. preliminary results in patients with at least two previous pregnancies affected by ntds, despite folic acid supplementation, indicate that periconceptional treatment with 500 mg/day of inositol (three months before conception and two months after) is able to prevent ntds recurrence in humans. recently, caffeine intake (more than 10 mg/day) has been associated with an increased risk of ntds, especially for subgroups of people that carry genetic variants for enzymes involved in caffeine metabolism. the teratogenic effects of caffeine are known since the 70s. indeed, gynecologists suggest to pregnant women to avoid/reduce caffeine intake. it is still unknown, however, whether pre-conception caffeine intake interferes with prophylactic therapy for ntds. in the proposed study, we aim to evaluate the effect of "espresso" consumption (corresponding to about 100 mg caffeine) on the pharmacokinetics of oral administered myo-inositol (mi), in order to highlight any possible negative effects of caffeine on mi adsorption and excretion before conception. the study will consist of two phases and will be carried on twelve healthy volunteers. during phase 1, volunteers will be kept for 15 days under inositol-poor diet; at the end of this period, 20 g of mi will be administrated in a single dose. basal levels of serum and urinary concentration will be evaluated before mi administration (t0); subsequently, sampling will be performed 2, 4, 6 and 8 hours after mi administration. phase 2 will consist of 15 additional days of inositol-poor diet: basal levels of mi will be again measured before mi administration. in phase 2, mi administration will be concomitant to caffeine exposure through single"espresso" consumption. samples will be collected at the same time points as in phase 1.


Eligibility criteria:
inclusion criteria: * bmi 18 to 24 exclusion criteria: * on going pregnancies * pharmacological treatment in the last 2 weeks * chronic diseases * diabetes

Keywords: inositol caffeine ntds
impact of negative pressure wound therapy on free muscle flaps

Conditions: Negative-Pressure Wound Therapy; Edema; Free Flap; Microcirculation; Macrocirculation

Summary: aim of the study is to prove the utility and safety of the negative pressure wound therapy (npwt) in the postoperative management of free flaps. the quantitative assessment of the entirety of clinical main relevant parameters like edema formation, microcirculation, macrocirculation and wound healing should create a better and comprehensive understanding of the npwt effects in this field.

this study evaluates the impact of negative pressure wound therapy on free muscle flaps. flaps were treated with npwt or with a conventional dressing (control) for five days following tissue transfer. edema formation is measured by a 3d scan (artec spidertm) during the operation, five and fourteen days after surgery. the macrocirculation- and microcirculation parameters of the flaps are assessed using an implanted doppler probe (cook-swartz®) as well as combined flowmetry and remission spectroscopy (o2c®). these measurements are conducted daily at the day of the operation as well as the first five days following the operation. following dressing removal at the fifth postoperative day, skin graft take is assessed.

Eligibility criteria:
inclusion criteria: * patients requiring free muscle flap reconstruction at the lower extremity covered with a split thickness skin graft * existing cognitive faculty * consent exclusion criteria: * non-compliance * non-consent
posttraumatic hypopituitarism - incidence, predictors and test validity

Conditions: Traumatic Brain Injury; Hypopituitarism

Summary: the purpose of the study is to estimate the incidence of posttraumatic hypopituitarism, and to identify predisposing factors in order to establish a rational responsible socioeconomic screening program.


Eligibility criteria:
inclusion criteria: * international classification of diseases (icd) 10 code s06.0-06.9 * age 18 - 65 years at time of traumatic brain injury * duration of hospitalization \> 24 hours. exclusion criteria: * known pituitary disease * clinically significant liver or renal disease * breast-feeding * pregnancy * alcohol or drug abuse

Keywords: traumatic brain injury hypopituitarism incidence
evaluating the need for the pseudophakic intraoperative abberrometry in toric iol implantation

Conditions: Cataract; Nuclear Sclerosis; Cortical Cataract; Posterior Subcapsular Cataract; Astigmatism

Summary: to determine clinically significant difference in results obtained from cataract surgery using ia. one eye will receive aphakic measurements only and the fellow eye will receive aphakic and then pseudophakic measurements when implanting a toric iol.

to determine if there is a clinically significant difference in the results obtained for the toric iol implantation when using ia to measure the aphakic eye only and when using ia to measure the aphakic eye and then the pseudophakic eye, with toric iol implantation.

Eligibility criteria:
inclusion criteria: * willing and able to understand and sign an informed consent * willing and able to attend all study visits * presenting for uncomplicated bilateral cataract surgery and have an interest in a toric iol * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error) * have visually significant cataracts * have regular corneal astigmatism of 1.0d to 5.0d in both eyes with a difference between eyes of 1.0d or less * have potential post operative acuity of 20/25 or better exclusion criteria: * corneal pathology * amblyopia * prior corneal refractive surgery or other refractive surgery * previous anterior or posterior chamber surgery that the investigator feels may compromise visual outcomes * diabetic retinopathy if the investigator feels this will compromise visual outcomes * macular degeneration * history of retinal detachment * irregular astigmatism or keratoconus * strabismus * if in the surgeon's opinion the subject is not an appropriate candidate for iol implantation * subjects who have an acute or chronic disease or illness that would confound the results of this investigation

Keywords: cataract surgery cataract toric iol
measure of the potential evoked by electric stimulation

Conditions: Low Grade Glioma of Brain

Summary: this study is about an experimental biomedical monocentric search concerning twelves patients presenting a infiltrative glioma of low rank oms type ii and realizing a surgery awakened on the site of the chu of montpellier. the objective of this search is to understand exactly how the electric impulses, delivered by the neurosurgeon to make a functional mapping of the brain during the surgery awakened by tumors infiltrates of low rank, propagate in this one and to identify the nervous networks inhibited by these electric impulses. having verified the eligibility of the patients and having obtained their consent, they will be included in the study. before the beginning of the surgery, the electroencephalography activity of the brain of every patient will be recorded. before and after the surgical resection, the electrocorticography activity will be recorded. the collected data will then be analyzed, after the operation. analyses will try to identify what we call potential evoked by the stimulation and which are small electric waves which appear after the electric stimulation was delivered.

all the surgical operations will be realized by professor hugues duffau. the demar-inria team will assure the collection and the data processing electrophysiological, the management of the data and the methodological follow-up, as well as the writing of the report and the distribution of the results. the quality assurance will be assured by a "minimal" monitoring by an assistant of clinical research for the department of the research and the innovation, to montpellier, which will verify principally the consents. the electrophysiological data digitized will be stored in the form of computer files via powerlab. all the analyses of treatment of signals required to highlight the potential evoked will be realized with the software matlab.

Eligibility criteria:
inclusion criteria: * patient carrier of a low-rank infiltrative glioma (oms type ii) and presenting the indications to benefit from a surgical care in condition awakened for the first time. * patient capable of understanding the nature, the purpose and the methodology of the research. * having signed an informed consent writes before the inclusion in the research. * membership or beneficiary of a national insurance scheme exclusion criteria: * systematic pathology with neurological appearance * psychiatric disorders * history of psychotic disorders * history of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology * major protected by the law (supervision or guardianship) * loss of liberty by court or administrative order

Keywords: mapping brain functions direct electric stimulation (des) potential evoked
comparison of laparoscopic procedures with and without the aid of the autolap system- a robotic camera holder

Conditions: General Laparoscopic Surgeries

Summary: the objective of this study is to evaluate the ability to reduce the number of or personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the autolap system compared with the standard operation.


Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years 2. able to provide a written informed consent exclusion criteria: 1. pregnancy 2. obesity (bmi \>35 kg/m2) 3. contra-indications for performing laparoscopy

Keywords: laparoscope holder colon resection right hemicolectomy left hemicolectomy sigmoid resection anti-reflux hiatal hernia
the aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.

Conditions: Spinal Surgery

Summary: chloride-rich isotonic crystalloid solutions have been shown to exert electrolyte imbalance and metabolic acidosis in critically ill patients. the aim of this investigation is to compare the influence of 0.9% saline and plasmalyte solution on acid-base balance and electrolytes in healthy patients undergoing major spine surgeries.


Eligibility criteria:
inclusion criteria: 1.50 patients (aged 20-65) undergoing cervical or lumbar spine surgery who were diagnosed spinal stenosis involving more than tow spinal levels. exclusion criteria: 1. asa class iii or iv 2. pregnancy 3. breast feeding 4. lack of mental weakness(including disabled) 5. using diuretics 6. respiratory insufficiency 7. metabolic acidosis or alkalosis 8. coagulation disorder 9. over hydtration 10. renal failure or serum creatinine \> 1.4mg/dl 11. anemia (hemoglobin 9.0\<mg/dl) 12. hypernatremia (na \> 145meq/l) 13. hyperkalemia (k\>5.5meq/l) 14. psychological medication or any drugs that influences renal clearance

Keywords: metabolic acidosis, plasmalyte solution, 0.9% normal saline
first-day high dose vitamin c, e in severe birth asphyxia

Conditions: Birth Asphyxia

Summary: to study the role of first-day high dose oral vitamin c and first-day single high dose oral vitamin e in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.

design: a prospective, randomized controlled trial over 5 months. patients: newborns admitted within 6 hours after birth with gestation \>32 weeks, apgar score of \<6 at 5 minutes, features suggestive of neonatal encephalopathy. intervention: after randomization, group a newborns received oral vitamin c 250 mg once a day within a 24-hour interval along with a single dose of vitamin e 200 iu. group b newborns received no intervention. outcome measures: severity and progression of birth asphyxia, duration of hospitalization and mechanical ventilation, mortality, and neurodevelopmental outcome.

Eligibility criteria:
inclusion criteria 1. apgar score of \<6 at 5 minutes 2. clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia) exclusion criteria 1. newborn hospitalized in neonatal intensive care unit (nicu) after 6 hours of birth 2. gestational age \<32 weeks. 3. lethal congenital anomaly

Keywords: oral vitamin c and oral vitamin e
intermittent hypoxia paired with high intensity training in brain injury

Conditions: Brain Injuries

Summary: the central hypotheses are that hit combined with aih results in: 1) greater locomotor gains as compared to hit alone; 2) improvements in gait quality and motor coordination during walking, and 3) changes in measures of community participation and integration.

the central hypotheses are that hit combined with aih results in: 1) greater locomotor gains as compared to hit alone; 2) improvements in gait quality and motor coordination during walking, and 3) changes in measures of community participation and integration. to test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (rct) is designed to test the effects of safety, feasibility, and preliminary efficacy of hit+aih. in this phase i-ii trial, patients \>6 months post-bi with mobility deficits will be allocated to 5 weeks (15 sessions) of hit+aih or hit alone. blinded assessments will be performed prior to and following training paradigms to address 3 specific aims.

Eligibility criteria:
inclusion criteria: * \> 6 months post brain injury * 18-85 years old * ability to walk without physical assistance * self selected walking speed of 0.01-1.0 m/s exclusion criteria: * \<18 years old * \>85 years old * self selected walking speed of \> 1.0 m/s * \< 3 months from botulinum toxin injection above the knee brace * currently receiving physical therapy